Drug Safety Alerts
Consumer-oriented pharmaceutical informationDrug Safety Alerts
The Food and Drug Administration (FDA) routinely publishes a variety of alerts on its MedWatch system related to safety issues with pharma products.
The agency receives complaints and other safety-related information from health care providers, manufacturers, and consumers on Medwatch, as well as notifications of safety issues from manufacturers.
When the FDA deems it to be appropriate based on the severity of the issue, the volume of complaints or other factors, it will issue a warning or safety alert to health care providers and the public, which is often accompanied by a recall notice issued by the manufacturer to remove affected products from the market.
Warnings and safety alerts can include:
- Product issues.
- Ancillary issues that can be a safety hazard, such as labeling.
- Recalls.
- Any other information related to a negative effect on the safe use of a product.
AvKARE Recalls Atovaquone Oral Suspension
AvKARE Recalls Atovaquone Oral Suspension AvKARE, LLC has issued a voluntary recall of lot # AW0221A of Atovaquone Oral Suspension, USP 750mg/5mL due to potential Bacillus cereus contamination found during stability testing at a third-party lab. The affected...
FDA Warns of Risks with OTC Pain Relief Products
The U.S. Food and Drug Administration (FDA) has issued a stern warning to consumers regarding the use of certain over-the-counter analgesic (pain relief) products intended for topical use before, during, or after various cosmetic procedures like microdermabrasion,...
FDA Drug Safety Alerts
| Date | Subject | More information |
|---|---|---|
| 2/23/2024 | FDA issues final decision to withdraw approval of Pepaxto (melphalan flufenamide) | Safety Communication |
| 1/31/2024 | FDA warns consumers of contaminated copycat eye drops | Safety Communication |
| 1/17/2024 | FDA announces shelf-life extension for naloxone nasal spray | Safety Communication |
| 12/27/2023 | FDA requires updates to labeling for promethazine hydrochloride injection products | Safety Communication |
| 11/21/2023 | FDA warns consumers not to purchase or use Neptune’s Fix or any tianeptine product due to serious risks | Safety Communication |
| 11/3/2023 | FDA warns consumers of hidden drug ingredients in Dr. Ergin’s SugarMD Advanced Glucose Support | Safety Communication |
| 10/27/2023 | FDA warns consumers not to purchase or use certain eye drops from several major brands due to risk of eye infection | Safety Communication |
| 9/18/2023 | FDA is changing the therapeutic equivalence rating for Accord Healthcare Inc.’s generics of Prograf (tacrolimus) oral capsules | Safety Communication |
| 8/22/2023 | FDA warns consumers not to purchase or use certain methylsulfonylmethane (MSM) eye drops due to contamination | Safety Communication |
| 8/1/2023 | FDA warns consumers that Tydemy, a prescription oral contraceptive, may have reduced effectiveness | Safety Communication |
| 5/22/2023 | G-Supress DX Pediatric Cough Drops may have incorrect drug in packaging | Safety Communication |
| 5/1/2023 | FDA warns consumers to not purchase or use Nose Slap and Soul Slap products marketed for alertness and energy boosting | Safety Communication |
| 2/9/2023 | Infants at Risk for Aluminum Toxicity with Unapproved Potassium Phosphates Drug Product | Safety Communication |
| 2/2/2023 | FDA warns consumers not to purchase or use EzriCare Artificial Tears due to potential contamination | Safety Communication |